ACTIS 2010-02-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295393764), received between Aug 2, 2018 and Sep 9, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (13 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Break; Device-Device Incompatibility

  It was reported that the Broaches were broke during a case. Surgeon needed to order all new sets of broaches with the new Design in case this happens again.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50689339 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT THE LINER TRIALS AND NECK SEGMENT ARE BROKEN. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086000 ↗
• MalfunctionMay 30, 2023Break; Break

  IT WAS REPORTED THAT THE RING AROUND THE NECK SEGMENT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020128 ↗
• MalfunctionSep 30, 2020Loose or Intermittent Connection; Device-Device Incompatibility; Material Twisted/Bent; Loose or Intermittent Connection; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE ACTIS TRIAL NECK SEGMENTS LOOSE TOLERANCE AND SLIGHTLY DISENGAGING WHEN TRIALING HIP. NO PROBLEMS WERE CAUSED DUE TO WORN INSTRUMENT. NEW NECK SEGMENTS WERE SWAPPED TO ADDRESS THIS ISSUES. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10606209 ↗
• MalfunctionSep 30, 2020Loose or Intermittent Connection; Device-Device Incompatibility; Material Twisted/Bent; Loose or Intermittent Connection; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE ACTIS TRIAL NECK SEGMENTS LOOSE TOLERANCE AND SLIGHTLY DISENGAGING WHEN TRIALING HIP. NO PROBLEMS WERE CAUSED DUE TO WORN INSTRUMENT. NEW NECK SEGMENTS WERE SWAPPED TO ADDRESS THIS ISSUES. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10606071 ↗
• MalfunctionOct 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ACTIS TRIAL NECKS KEEP SLIDING OFF BROACHES . THEY CALLED R.O IN HIP MARKETING AND TOLD THEY HAVE FIXED THIS ISSUE IN THE NEWER SETS. NEEDING TO GET THREE SETS OF TRIAL NECKS FOR ACTIS STANDARD AND HIGH OFFSET . R.O TOLD HIM TO FILL OUT MDR FORM AND I CLD GET OLDER STYLE ACTIS NECKS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217824 ↗
• MalfunctionOct 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ACTIS TRIAL NECKS KEEP SLIDING OFF BROACHES . THEY CALLED R.O IN HIP MARKETING AND TOLD THEY HAVE FIXED THIS ISSUE IN THE NEWER SETS. NEEDING TO GET THREE SETS OF TRIAL NECKS FOR ACTIS STANDARD AND HIGH OFFSET . R.O TOLD HIM TO FILL OUT MDR FORM AND I CLD GET OLDER STYLE ACTIS NECKS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217822 ↗
• MalfunctionOct 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ACTIS TRIAL NECKS KEEP SLIDING OFF BROACHES. THEY CALLED R.O IN HIP MARKETING AND TOLD THEY HAVE FIXED THIS ISSUE IN THE NEWER SETS. NEEDING TO GET THREE SETS OF TRIAL NECKS FOR ACTIS STANDARD AND HIGH OFFSET. R.O TOLD HIM TO FILL OUT MDR FORM AND I CLD GET OLDER STYLE ACTIS NECKS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217816 ↗
• MalfunctionMay 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  NECK SEGMENT IS LOOSE ON BROACH PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4); DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4); DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4); DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4); DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4); DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4); DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4); DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4); DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4); DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4); DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4); DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633954 ↗
• MalfunctionMay 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  NECK SEGMENT IS LOOSE ON BROACH. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633857 ↗
• MalfunctionMay 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  NECK SEGMENT IS LOOSE ON BROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8631927 ↗
• MalfunctionMay 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  NECK SEGMENT IS LOOSE ON BROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8629116 ↗
• MalfunctionMay 8, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ACTIS NECK TRIALS HAVE BEEN COMING APART DURING TRIAL REDUCTIONS. FORCING THE SURGEON TO DISLOCATE HIP, DROP THE LEG, RECONNECT THE NECK TRIAL, AND REDUCE THE HIP AGAIN. THIS HAS BEEN AN ONGOING ISSUE WITH OUR SETS, AND HAS ADDED TIME TO PROCEDURES. WE HAVE 3 SETS IN OUR HOSPITAL THAT NEED TO BE CHANGED OUT.

  Patient problems: Not Applicable

  MAUDE report 8591479 ↗
• MalfunctionMay 8, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ACTIS NECK TRIALS HAVE BEEN COMING APART DURING TRIAL REDUCTIONS. FORCING THE SURGEON TO DISLOCATE HIP, DROP THE LEG, RECONNECT THE NECK TRIAL, AND REDUCE THE HIP AGAIN. THIS HAS BEEN AN ONGOING ISSUE WITH OUR SETS, AND HAS ADDED TIME TO PROCEDURES. WE HAVE 3 SETS IN OUR HOSPITAL THAT NEED TO BE CHANGED OUT.

  Patient problems: Not Applicable

  MAUDE report 8591391 ↗
• MalfunctionMay 8, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ACTIS NECK TRIALS HAVE BEEN COMING APART DURING TRIAL REDUCTIONS. FORCING THE SURGEON TO DISLOCATE HIP, DROP THE LEG, RECONNECT THE NECK TRIAL, AND REDUCE THE HIP AGAIN. THIS HAS BEEN AN ONGOING ISSUE WITH OUR SETS, AND HAS ADDED TIME TO PROCEDURES. WE HAVE 3 SETS IN OUR HOSPITAL THAT NEED TO BE CHANGED OUT.

  Patient problems: Not Applicable

  MAUDE report 8591168 ↗
• MalfunctionAug 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  USER REPORTED THAT FOR THE ACTIS TRIAL NECKS "IT WOULD BE AN IMPROVEMENT IF THE ¿FEMALE" TRIAL NECK HAD AN O RING IN THE HOLE SO THAT THE NECK WOULD NOT COME OFF DURING TRIAL REDUCTION AND DISLOCATION." COMPLAINT BEING RAISED AS USE INDICATED THAT THE NECK WOULD COME OFF DURING TRIALING AND DISLOCATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7742515 ↗